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Hepatic Impairment Study for Lorlatinib in Cancer Patients

NCT03726333 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2024-06-21

Study results available
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Summary

This is a phase 1 study in advanced cancer patients with varied hepatic functions to evaluate the potential effect of hepatic impairment on pharmacokinetics and safety of lorlatinib and provide dose recommendation for patients with hepatic impairment if possible.

Conditions

Interventions

DRUG

lorlatinib

continued daily administration of 100 mg lorlatinib

DRUG

lorlatinib

continued daily administration of lorlatinib at the dose level same as Group C for the first 22 days and 100 mg QD afterwards

DRUG

lorlatinib

continued daily administration of 100 mg QD lorlatinib

DRUG

lorlatinib

continued daily administration of lorlatinib at 50 mg QD initially and may be adjusted based on PK and safety results from the initial several patients

DRUG

lorlatinib

continued daily administration of lorlatinib at the dose level determined based on preliminary PK and safety results from first several patients in Group C

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-14
Primary Completion
2021-07-08
Completion
2021-07-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03726333 on ClinicalTrials.gov